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SOFIPERLA 75MICROGRAMS/30MICROGRAMS TABLETS

Active substance(s): ETHINYLESTRADIOL / GESTODENE

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Are you experiencing any of these signs?
Package leaflet: Information for the user

Sofiperla 75micrograms/30micrograms Tablets
Gestodene/Ethinylestradiol

Important things to know about combined hormonal
contraceptives (CHCs):
• They are one of the most reliable reversible methods of
contraception if used correctly.
• They slightly increase the risk of having a blood clot in the veins
and arteries, especially in the first year or when restarting a
combined hormonal contraceptive following a break of 4 or more
weeks.
• Please be alert and see your doctor if you think you may have
symptoms of a blood clot (see section 2 “Blood clots”).
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions or need more advice, ask your
doctor, family planning nurse, or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Sofiperla is and what it is used for
2. What you need to know before you take Sofiperla
3. How to take Sofiperla
4. Possible side effects
5. How to store Sofiperla
6. Contents of the pack and other information
1. What Sofiperla is and what it is used for
• Sofiperla is a contraceptive tablet and is used to prevent pregnancy.
• Each tablet contains a small amount of two different female
hormones, namely ethinylestradiol and gestodene.
• Contraceptive tablets as Sofiperla that contain two hormones are
called “combination” contraceptives.
2. What you need to know before you take Sofiperla
General notes
Before you start using Sofiperla you should read the information
on blood clots in section 2. It is particularly important to read the
symptoms of a blood clot – see Section 2 “Blood clots”.

• s udden unexplained breathlessness or rapid
breathing;
• sudden cough without an obvious cause,
which may bring up blood
• sharp chest pain which may increase with
deep breathing
• severe light headedness or dizziness
• rapid or irregular heartbeat
• severe pain in your stomach

What are you
possibly suffering
from?

Pulmonary
embolism

If you are unsure, talk to a doctor as some of
these symptoms such as coughing or being
short of breath may be mistaken for a milder
condition such as a respiratory tract infection
(e.g. a ‘common cold’).
Symptoms most commonly occur in one eye:
Retinal vein
• immediate loss of vision or
thrombosis (blood
• painless blurring of vision which can
clot in the eye)
progress to loss of vision.
•  chest pain, discomfort, pressure, heaviness
sensation of squeezing or fullness in
the chest, arm or below the breastbone
• fullness, indigestion or choking feeling
• upper body discomfort radiating to the
back, jaw, throat, arm and stomach
• sweating, nausea, vomiting or dizziness
• extreme weakness, anxiety, or shortness of
breath
• rapid or irregular heartbeats.
• s udden weakness or numbness of the face,
arm or leg, especially on one side of the
body
• sudden confusion, trouble speaking or
understanding
• sudden trouble seeing in one or both eyes
• sudden trouble walking, dizziness, loss of
balance or coordination
• sudden, severe or prolonged headache
with no known cause
• loss of consciousness or fainting with or
without seizure.

Heart attack

Stroke

Sometimes the symptoms of stroke can
be brief with an almost immediate and full
recovery, but you should still seek urgent
medical attention as you may be at risk of
another stroke.

Before you can begin taking Sofiperla, your doctor will ask you some
questions about your personal health history and that of your close
Blood clots
• swelling and slight blue discolouration of
relatives. The doctor will also measure your blood pressure, and
blocking other
an extremity
depending upon your personal situation, may also carry out some
blood vessels
• severe pain in your stomach (acute
other tests. In this leaflet, several situations are described where you
abdomen).
should stop using Sofiperla, or where the reliability of Sofiperla may be
decreased. In such situations you should either not have intercourse
BLOOD CLOTS IN A VEIN
or you should take extra non-hormonal contraceptive precautions,
What can happen if a blood clot forms in a vein?
e.g., a condom or another barrier method. Do not use rhythm or
• The use of combined hormonal contraceptives has been
temperature methods. These methods can be unreliable because
connected with an increase in the risk of blood clots in the vein
Sofiperla alters the monthly changes of the body temperature and of
(venous thrombosis). However, these side effects are rare. Most
the cervical mucus.
frequently, they occur in the first year of use of a combined
hormonal contraceptive.
Sofiperla, like other hormonal contraceptives, does not protect
• If a blood clot forms in a vein in the leg or foot it can cause a deep
against HIV infection (AIDS) or any other sexually transmitted
vein thrombosis (DVT).
disease.
• If a blood clot travels from the leg and lodges in the lung it can
cause a pulmonary embolism.
When you should not use Sofiperla
• Very rarely a clot may form in a vein in another organ such as the
You should not use Sofiperla if you have any of the conditions listed
eye (retinal vein thrombosis).
below. If you do have any of the conditions listed below, you must
tell your doctor. Your doctor will discuss with you what other form of When is the risk of developing a blood clot in a vein highest?
birth control would be more appropriate.
The risk of developing a blood clot in a vein is highest during the first
• if you have (or have ever had) a blood clot in a blood vessel of your year of taking a combined hormonal contraceptive for the first time.
legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, The risk may also be higher if you restart taking a combined hormonal
PE) or other organs
contraceptive (the same product or a different product) after a break
• if you know you have a disorder affecting your blood clotting – for of 4 weeks or more.
instance, protein C deficiency, protein S deficiency, antithrombin-III After the first year, the risk gets smaller but is always slightly higher
deficiency, Factor V Leiden or antiphospholipid antibodies
than if you were not using a combined hormonal contraceptive.
• if you need an operation or if you are off your feet for a long time
When you stop Sofiperla your risk of a blood clot returns to normal
(see section ‘Blood clots’)
within a few weeks.
• if you have ever had a heart attack or a stroke
• if you have (or have ever had) angina pectoris (a condition that
What is the risk of developing a blood clot?
causes severe chest pain and may be a first sign of a heart attack)
The risk depends on your natural risk of VTE and the type of
or transient ischaemic attack (TIA – temporary stroke symptoms)
combined hormonal contraceptive you are taking.
• if you have any of the following diseases that may increase your risk The overall risk of a blood clot in the leg or lung (DVT or PE) with
of a clot in the arteries:
Sofiperla is small.
– severe diabetes with blood vessel damage
- Out of 10,000 women who are not using any combined hormonal
– very high blood pressure
contraceptive and are not pregnant, about 2 will develop a blood
– a very high level of fat in the blood (cholesterol or triglycerides)
clot in a year.
– a condition known as hyperhomocysteinaemia
- Out of 10,000 women who are using a combined hormonal
• if you have (or have ever had) a type of migraine called ‘migraine
contraceptive that contains levonorgestrel, norethisterone, or
with aura’
norgestimate about 5-7 will develop a blood clot in a year.
• if you have (had) an inflammation of the pancreas (pancreatitis)
- Out of 10,000 women who are using a combined hormonal
• if you have or have had a liver disease and your liver function is still
contraceptive that contains gestodene such as Sofiperla between
not normal
about 9 and 12 women will develop a blood clot in a year.
• if you have or have had a tumour in the liver
- The risk of having a blood clot will vary according to your personal
• if you have (had) or if you are suspected of having breast cancer or
medical history (see “Factors that increase your risk of a blood clot”
cancer of the genital organs
below).
• if you have any unexplained bleeding from the vagina
• if you are pregnant or think you may be pregnant
Risk of developing a blood clot in
• if you are allergic to ethinylestradiol or gestodene, or any of the
a year
other ingredients of Sofiperla (listed in section 6). This can be
Women who are not using
recognised by itching, rash or swelling.
a combined hormonal pill/
About 2 out of 10,000 women
patch/ring and are not
Warnings and precautions
pregnant
Talk to your doctor, pharmacist or nurse before taking this medicine.
When should you contact your doctor?
Seek urgent medical attention
If you notice possible signs of a blood clot that may mean you are
suffering from a blood clot in the leg (i.e. deep vein thrombosis), a
blood clot in the lung (i.e. pulmonary embolism), a heart attack or a
stroke (see ‘Blood clot’ (thrombosis) section below.
For a description of the symptoms of these serious side effects
please go to “How to recognise a blood clot”.

Women using a combined
hormonal contraceptive pill
containing levonorgestrel,
norethisterone or
norgestimate

About 5-7 out of 10,000 women

Women using Sofiperla

About 9-12 out of 10,000 women

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Sofiperla is small but some conditions
will increase the risk. Your risk is higher:
Tell your doctor if any of the following conditions apply to you.
• if you are very overweight (body mass index or BMI over 30kg/m2)
If the condition develops, or gets worse while you are using Sofiperla, • if one of your immediate family has had a blood clot in the leg,
you should also tell your doctor.
lung or other organ at a young age (e.g. below the age of about
• if you have Crohn’s disease or ulcerative colitis (chronic
50). In this case you could have a hereditary blood clotting
inflammatory bowel disease)
disorder
• if you have systemic lupus erythematosus (SLE – a disease affecting • if you need to have an operation, or if you are off your feet for a
your natural defence system)
long time because of an injury or illness, or you have your leg in a
• if you have haemolytic uraemic syndrome (HUS - a disorder of
cast. The use of Sofiperla may need to be stopped several weeks
blood clotting causing failure of the kidneys)
before surgery or while you are less mobile. If you need to stop
• if you have sickle cell anaemia (an inherited disease of the red
Sofiperla ask your doctor when you can start using it again
blood cells)
• as you get older (particularly above about 35 years)
• if you have elevated levels of fat in the blood (hypertriglyceridaemia) • if you gave birth less than a few weeks ago.
or a positive family history for this condition. Hypertriglyceridaemia
has been associated with an increased risk of developing
The risk of developing a blood clot increases the more conditions you
pancreatitis (inflammation of the pancreas)
have.
• if you need an operation, or you are off your feet for a long time
Air travel (>4 hours) may temporarily increase your risk of a blood clot,
(see in section 2 ‘Blood clots’)
particularly if you have some of the other factors listed.
• if you have just given birth you are at an increased risk of blood
clots. You should ask your doctor how soon after delivery you can It is important to tell your doctor if any of these conditions apply to
you, even if you are unsure. Your doctor may decide that Sofiperla
start taking Sofiperla
• if you have an inflammation in the veins under the skin (superficial needs to be stopped.
thrombophlebitis)
If any of the above conditions change while you are using Sofiperla,
• if you have varicose veins
for example a close family member experiences a thrombosis for no
• if a close relative has (had) breast cancer or breast cancer was
known reason; or you gain a lot of weight, tell your doctor.
diagnosed
• if you have a disease of the liver or the gallbladder
BLOOD CLOTS IN AN ARTERY
• if you have diabetes
What can happen if a blood clot forms in an artery?
• if you have depression
Like a blood clot in a vein, a clot in an artery can cause serious
• if you have epilepsy (see section “Other medicines and Sofiperla”)
problems. For example, it can cause a heart attack or a stroke.
• if you have a disease that first appeared during pregnancy or
earlier use of sex hormones (for example, hearing loss, porphyria
Factors that increase your risk of a blood clot in an artery
(a disease of the blood), gestational herpes (skin rash with vesicles
It is important to note that the risk of a heart attack or stroke from
during pregnancy), Sydenham’s chorea (a disease of the nerves in
using Sofiperla is very small but can increase:
which sudden movements of the body occur)
• with increasing age (beyond about 35 years)
• if you have (had) chloasma (golden brown pigment patches, so
• if you smoke. When using a combined hormonal contraceptive like
called “pregnancy patches”, especially on the face). If this is the
Sofiperla you are advised to stop smoking. If you are unable to stop
case, avoid direct exposure to sunlight or ultraviolet light
smoking and are older than 35 your doctor may advise you to use a
• if you have hereditary angioedema (severe allergic reaction),
different type of contraceptive
products containing estrogens may induce or worsen symptoms
• if you are overweight
of angioedema. You should see your doctor immediately if you
• if you have high blood pressure
experience symptoms of angioedema such as swollen face, tongue • if a member of your immediate family has had a heart attack or
and/or pharynx and/or difficulty swallowing or hives together with
stroke at a young age (less then about 50). In this case you could
difficulty breathing.
also have a higher risk of having a heart attack or stroke
• if you, or someone in your immediate family, have a high level of
BLOOD CLOTS
fat in the blood (cholesterol or triglycerides)
Using a combined hormonal contraceptive such as Sofiperla
• if you get migraines, especially migraines with aura
increases your risk of developing a blood clot compared with not
• if you have a problem with your heart (valve disorder, disturbance
using one. In rare cases a blood clot can block blood vessels and
of the rhythm called atrial fibrillation)
cause serious problems.
• if you have diabetes.
Blood clots can develop
If you have more than one of these conditions or if any of them
• in veins (referred to as a ‘venous thrombosis’, ‘venous
are particularly severe the risk of developing a blood clot may be
thromboembolism’ or VTE)
increased even more.
• in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial
If any of the above conditions change while you are using Sofiperla,
thromboembolism’ or ATE).
for example you start smoking, a close family member experiences a
thrombosis for no known reason; or you gain a lot of weight, tell your
Recovery from blood clots is not always complete. Rarely, there may doctor.
be serious lasting effects or, very rarely, they may be fatal.
Sofiperla and cancer
It is important to remember that the overall risk of a harmful blood Breast cancer has been observed slightly more often in women
clot due to Sofiperla is small.
using combined contraceptives, but it is not known whether this is
caused by the treatment. For example it may be that more tumours
HOW TO RECOGNISE A BLOOD CLOT
are detected in women on combined contraceptives because they
Seek urgent medical attention if you notice any of the following signs are examined by their doctor more often. The occurrence of breast
tumours becomes gradually less after stopping the combination
or symptoms.
hormonal contraceptives. It is important to regularly check your
What are you
breasts and you should contact your doctor if you feel any lump.
Are you experiencing any of these signs?
possibly suffering
from?
In rare cases, benign liver tumours, and in even fewer cases malignant
liver tumours have been reported in contraceptives users. This can
• Swelling of one leg or along a vein in the
cause internal bleeding leading to severe pain in the abdomen.
leg or foot especially when accompanied
by:
Contact your doctor if you have unusual severe abdominal pain. You
Deep vein
• pain or tenderness in the leg which may
may need to stop taking Sofiperla.
thrombosis
be felt only when standing or walking
• increased warmth in the affected leg
Cervical cancer has been reported to occur more often in women
• change in colour of the skin on the leg
using contraceptives for a long time. This finding may not be caused
e.g. turning pale, red or blue.
by the contraceptives, but may be related to sexual behaviour and
other factors

Gestodene/Ethinylestradiol 75/30Mcg -,Pil, United Kingdom

colours/plates:
1. Black

item no: AAAH5138

dimensions: 222 x 680

print proof no: 04

pharmacode:

origination date: 16/12/14

min pt size: 9 pts

3.
4.
5.
6.

originated by: C.Grant
approved for print/date

2.

revision date: 22/12/14

Technical Approval

revised by: C.Grant

date sent: 16/12/14

supplier: Leon Farma S.A

technically app. date:

Non Printing Colours
1.
2.
3.

Bleeding between periods
During the first few months that you are taking Sofiperla, you may
have unexpected bleeding (bleeding outside the gap week). If this
bleeding continues longer than a few months, or if it begins after
some months, your doctor must investigate the cause.

Yes

What you must do if no bleeding occurs in the gap week
If you have taken all the tablets correctly, have not had vomiting or
severe diarrhoea and you have not taken any other medicines, it is
highly unlikely that you are pregnant.
If the expected bleeding does not happen twice in succession, you
may be pregnant. Contact your doctor immediately. Do not start the
next strip until you are sure that you are not pregnant.
Other medicines and Sofiperla
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Always tell the doctor, who prescribes Sofiperla, which medicines
or herbal products you are already using. Also tell any other doctor
or dentist who prescribes another medicine (or the dispensing
pharmacist) that you use Sofiperla. They can tell you if you need to
take additional contraceptive precautions (for example condoms) and
if so, for how long.
• Some medicines can make Sofiperla less effective in preventing
pregnancy, or can cause unexpected bleeding.
These include medicines used for the treatment of epilepsy
(e.g. hydantoin, topiramate, felbamate, lamotrigine, primidone,
phenytoin, barbiturates, carbamazepine, oxcarbamazepine)
and tuberculosis (e.g. rifampicin), immunomodulating agents
(ciclosporin), HIV infections (ritonavir, nevirapin) or other
infectious diseases (rifabutin, griseofulvin, ampicillin, tetracycline),
antibiotics (penicillin and tetracyclins), anti-inflammation drugs
(phenylbutazone, dexamethasone), modafinil, theophylline,
cortecosteroids and the herbal remedy St. John’s wort.
• If you want to use herbal products containing St. John’s wort while
you are already using Sofiperla you should consult your doctor first.
• Sofiperla may decrease the efficacy of other medicines, e.g.
medicines containing cyclosporin (medicine against infections), the
anti-epileptic lamotrigine or valproat (this could lead to an increased
frequency of seizures) or levothyroxine.

Ask your doctor for advice.

More than 1 tablet forgotten in 1 strip

Had sex in the previous week before
forgetting?

In week 1

No

Only 1 tablet
forgotten (taken
more than 12
hours late)

•T
 ake the forgotten tablet
• Use a barrier method (condom) for the
following 7 days and
• Finish the strip
•T
 ake the forgotten tablet
• Finish the strip

In week 2

•T
 ake the forgotten tablet and finish
the strip
• Instead of the tablet-free period go
straight to the next strip
In week 3

Or
• S top the strip immediately
•G
 o directly to tablets-free period (not more
than 7 days including the forgotten tablet)
• T hen start the next strip

What you must do in the case of gastro-intestinal disturbances
In case of severe gastro-intestinal disturbances (e.g., vomiting
or diarrhoea), absorption may not be complete and additional
contraceptive measures should be taken. If you vomit within 3-4
hours of taking a tablet or you have severe diarrhoea, the situation is
similar to if you forget a tablet. After vomiting or diarrhoea, you must
take another tablet from a reserve strip as soon as possible. If possible
take it within 12 hours of when you normally take your tablet. If this
is not possible or 12 hours have passed, you should follow the advice
given under “If you forget to take Sofiperla”.

Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Delay of menstrual period: what you must know
Even if not recommended, delay of your menstrual period (withdrawal
bleed) is possible. This can be done by going straight on to a new strip
Laboratory tests
of Sofiperla instead of the tablet-free period, after the first strip. You
If you need a blood test, tell your doctor or the laboratory staff that
may experience spotting (drops or flecks of blood) or breakthrough
you are taking this medicine, because oral contraceptives can affect
bleeding while using this second strip. After the usual tablet-free
the results of some tests.
period of 7 days, continue with the following strip.
Pregnancy and breast-feeding
You might ask your doctor for advice before deciding to delay your
If you are pregnant or breast-feeding, think you may be pregnant or
menstrual period.
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
Change of the first day of your menstrual period: what you must
know
If you are pregnant, you must not take Sofiperla. If you become
If you take the tablets according to the instructions, then your
pregnant while taking Sofiperla you must stop immediately and
menstrual period/withdrawal bleed will begin in the tablet-free period.
contact you doctor.
If you have to change this day, you do this by making the tablet-free
period shorter (but never longer than 7 days!). For example, if your
Use of Sofiperla is generally not advisable when a woman is breasttablet-free period begins on a Friday, and you want to change this to
feeding. If you want to take the contraceptive while you are breasta Tuesday (3 days earlier) you must start a new strip 3 days earlier than
feeding you should contact your doctor.
usual. If you make the tablet-free period very short (for example, for 3
days or less) then it may be that you do not have any bleeding during
Driving and using machines
this tablet-free period. You may then experience spotting (droplets or
There is no information suggesting that use of Sofiperla affects driving flecks or blood) or breakthrough bleeding.
or use of machines.
If you are not sure how to proceed, contact your doctor for advice.
If you stop taking Sofiperla
Sofiperla contains lactose
You can stop taking Sofiperla whenever you want. If you do not want
If you have been told by your doctor that you have an intolerance
to become pregnant, ask your doctor for advice about other reliable
to some sugars, contact your doctor before taking this medicinal
methods of birth control.
product.
If you have any further questions on the use of this product, ask your
3. How to take Sofiperla
doctor or pharmacist.
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
Take one tablet of Sofiperla every day, if necessary with a small
amount of water. Your may take the tablets with or without food, but
should take the tablets every day at approximately the same time.
The strip contains 21 tablets. Next to each tablet the day of the week
is printed. If, for example you start on a Wednesday, take a tablet with
“WED” next to it. Follow the direction of the arrow on the strip until all
21 tablets have been taken.
Then take no tablets for 7 days. In the course of these 7 tablet-free
days (otherwise called a stop or gap week) bleeding should begin. This
so-called “withdrawal bleed” should occur during this time.
On the 8th day after the last tablet (that is, after the 7-day gap week),
start the following strip, even if the bleeding has not stopped. This
means that you should start the following strip on the same day of the
week and that the withdrawal bleed should occur during this time.
If you use Sofiperla in this manner, you are also protected against
pregnancy during the 7 days that you are not taking a tablet.
When can you start with the first strip
• If you have not used a contraceptive with hormones in the previous
month.
Begin with Sofiperla on the first day of the cycle (that is the first day
of your menstruation). If you start Sofiperla on the first day of your
menstruation you are immediately protected against pregnancy. You
may also begin on day 2-5 of the cycle, but then you must use extra
protective measures (for example, a condom) for the first 7 days.
• Changing from another combined hormonal contraceptive, or
combined contraceptive vaginal ring or patch.
You can start Sofiperla on the day after the tablet-free period of
your previous contraceptive finishes (or after the last inactive tablet
of your previous contraceptive). When changing from a combined
contraceptive vaginal ring or patch, follow the advice of your doctor.
• Changing from a preparation containing only a progestogen
(progestogen-only tablet, injection, implant or a progestogenreleasing IUD).
You may switch any day from an injectable when the next injection
would be due from the progestogen-only tablet and from an implant
or the IUD on the day of its removal). But in all of these cases you
must use extra protective measures (for example, a condom) for the
first 7 days of tablet-taking.
• After a miscarriage.
Follow the advice of your doctor.
• After having a baby.
After having a baby, you can start with Sofiperla between 21 and 28
days later. If you start later than day 28, you must use a so-called
barrier method (for example, a condom) during the first seven days
of Sofiperla use.
If, after having a baby, you have had intercourse before starting
Sofiperla (again), you must first be sure that you are not pregnant
otherwise you must wait until the next menstrual bleed.
Ask your doctor for advice in case you are not sure when to start
taking Sofiperla

4. Possible side effects
Like all medicines, Sofiperla can cause side effects, although not
everybody gets them. If you get any side effect, particularly if severe
and persistent, or have any change to your health that you think may
be due to Sofiperla, please talk to your doctor.
An increased risk of blood clots in your veins (venous
thromboembolism (VTE)) or blood clots in your arteries (arterial
thromboembolism (ATE)) is present for all women taking combined
hormonal contraceptives. For more detailed information on the
different risks from taking combined hormonal contraceptives please
see section 2 “What you need to know before you use Sofiperla”.
• harmful blood clots in a vein or artery for example:
- in a leg or foot (i.e. DVT)
- in a lung (i.e. PE)
- heart attack
- stroke
- mini-stroke or temporary stroke-like symptoms, known as a
transient ischaemic attack (TIA)
- blood clots in the liver, stomach/intestine, kidneys or eye.
The chance of having a blood clot may be higher if you have any
other conditions that increase this risk (See section 2 for more
information on the conditions that increase risk for blood clots and
the symptoms of a blood clot)
The following is a list of the side effects that have been linked with the
use of Sofiperla:
Common (may affect up to 1 in 10 women):
• headaches
• nervousness
• poor tolerance of contact lenses
• visual disturbances
• nausea
• acne
• migraine
• increase in weight
• fluid retentions
• bleeding and spotting between your periods can sometimes occur
for the first few months but this usually stops once your body has
adjusted to Sofiperla. If it continues, becomes heavy or starts again,
contact your doctor.
• absence of menstruations
• sore breasts
• loss of interest in sex
• depressive moods
• irritability.
Uncommon (may affect up to 1 in 100 women):
• excess of lipids in blood
• vomiting
• hypertension.
Rare (may affect up to 1 in 1,000 women):
• liver disease
• skin and subcutaneous tissue disorder (lupus erythematosus)
• middle ear disorders
• gallstones
• thrombosis (the formation of a clot in blood vessels)
• pigmentation disorders. This may happen even if you have been
using Sofiperla for a number of months. This may be reduced by
avoiding too much sunlight
• changes in vaginal secretion.
Very rare (may affect up to 1 in 10,000):
• movement disorders
• affection of the pancreas.

If you are breastfeeding and want to start Sofiperla (again) after having
a baby.
Sofiperla should not be used during breast feeding. Read the section 2.
Reporting of side effects
“Pregancy and breast feeding”.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can also
If you take more Sofiperla than you should
report side effects directly via the Yellow Card Scheme at:
There are no reports of serious harmful results of taking too many
www.mhra.gov.uk/yellowcard
Sofiperla tablets.
By reporting side effects you can help provide more information on
If you take several tablets at once then you may have symptoms of
the safety of this medicine.
nausea, dizziness, abdominal pain, drowsiness/fatigue or vomiting.
Young girls may have bleeding from the vagina.
5. How to store Sofiperla
If you have taken too many Sofiperla tablets, or you discover that a
child has taken some, ask your doctor or pharmacist for advice.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
If you forget to take Sofiperla
• If you are less than 12 hours late taking a tablet, the protection from strip and carton after EXP. The expiry date refers to the last day of that
pregnancy is not reduced. Take the tablet as soon as you remember month.
Do not store above 30°C. Keep the strip in the outer carton, in order
and then take the following tablets again at the usual time.
to protect from light.
• If you are more than 12 hours late taking a tablet, the protection
from pregnancy may be reduced. The greater the number of tablets Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
that you have forgotten, the greater is the risk that the protection
longer use. These measures will help protect the environment.
from pregnancy is reduced.
The risk of incomplete protection against pregnancy is greatest if you
forget a tablet at the beginning or the end of the strip. Therefore, you 6. Contents of the pack and other information
should adhere to the following rules (see also the diagram)
What Sofiperla contains
The active substances are gestodene and ethinylestradiol.
• If you forget more than one tablet in this strip
• Each tablet contains 75micrograms gestodene and 30micrograms
Contact your doctor.
ethinylestradiol
• If you forget one tablet in week 1
• The other ingredients are: lactose monohydrate, microcrystalline
Take the forgotten tablet as soon as you remember, even if that
cellulose, povidone K-30, magnesium stearate and polacrilin
means that you have to take two tablets at the same time. Take the
potassium.
tablets again at the usual time and use extra precautions for the
next 7 days, for example, a condom. If you have had intercourse in
What Sofiperla looks like and contents of the pack
the week before the oversight or you have forgotten to start a new
Sofiperla tablets are round, white tablets, with a diameter of 5.7mm
strip after the tablet-free period, you must realise that there is a risk
approximately and debossed with a ‘C’ on one side and ‘33’ on the
of pregnancy. In that case, contact your doctor.
other side.
• If you forget one tablet in week 2
Marketing Authorisation Holder
Take the forgotten tablet as soon as you remember, even if that
means that you have to take two tablets at the same time. Take the Actavis Group PTC ehf.
tablets again at the usual time. The protection from pregnancy is not Reykjavíkurvegi 76-78
220 Hafnarfjörður
reduced, and you do not need to take extra precautions.
Iceland
• If you forget one tablet in week 3
You can choose between two possibilities:
Manufacturer
1. Take the forgotten tablet as soon as you remember, even if that
Laboratorios León Farma, S.A.
means that you have to take two tablets at the same time. Take the C/ La Vallina s/n, Poligono Industrial Navatejera, 24008
tablets again at the usual time. Instead of the tablet-free period go Navatejera, León
straight on to the next strip.
Spain.
Most likely, you will have a period (withdrawal bleed) at the end of
the second strip but you may also have spotting or breakthrough
bleeding during the second strip.
2. You can also stop the strip and go directly to the tablet-free period
of 7 days (record the day on which you forgot your tablet). If you
want to start a new strip on your fixed start day, make the tablet-free
period less than 7 days.
If you follow either of these two recommendations, you will remain
protected against pregnancy.
• If you have forgotten any of the tablets in a strip, and you do not
have bleeding in the first tablet-free period, this may mean that you
are pregnant. You must contact your doctor before you go on to the
next strip.

This leaflet was last revised in December 2014

If you would like a
leaflet with larger text,
please contact
01271 385257.

AAAH5138

Gestodene/Ethinylestradiol 75/30Mcg -,Pil, United Kingdom

colours/plates:
1. Black

item no: AAAH5138

dimensions: 222 x 680

print proof no: 04

pharmacode:

origination date: 16/12/14

min pt size: 9 pts

3.
4.
5.
6.

originated by: C.Grant
approved for print/date

2.

revision date: 22/12/14

Technical Approval

revised by: C.Grant

date sent: 16/12/14

supplier: Leon Farma S.A

technically app. date:

Non Printing Colours
1.
2.
3.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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